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PET Scan with PF-03654746

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 4, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

PET Scan with PF-03654746 · 1 trial · 1 indication

Phase 1 1
NCT00730990A Phase I, Healthy Volunteer Positron Emission Tomography StudyHealthy
COMPLETED10 Analytics
PHASE1COMPLETED
A Phase I, Healthy Volunteer Positron Emission Tomography Study
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall H3 Receptor Occupancy of PF 03654746.
48 hours

Secondary Endpoints

Binding potential (BP) of [C-11]PF 04621053.
48 hours
Relationship between serum PF 03654746 concentration and H3 RO (IC50).
48 hours
H3 RO of PF 03654746 at regions of interest in man
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALThis arm will have no active treatment.
Cohort 2EXPERIMENTAL -

Interventions

NameTypeDescription
Positron Emission tomographyOTHERPositron Emission tomography scans. Part 1of the study : 4 subjects will receive 2 scans a day for 1 day with PET ligand administered in tracer quantities.
PET Scan with PF-03654746DRUGIf none of the data from Cohort 2 is informative, then: 2) an additional 3 subjects will receive 2 Scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746. Doses will be determined based upon the outcome of the first intervention.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical l...

Countries:United States
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Frequently asked questions about PET Scan with PF-03654746

What is PET Scan with PF-03654746 used for?

PET Scan with PF-03654746 is an investigational small molecule being studied in healthy volunteers. It is used in positron emission tomography (PET) imaging to visualize and measure the distribution of PF-03654746 in the body. The drug is in Phase 1 clinical development.

Who makes PET Scan with PF-03654746?

PET Scan with PF-03654746 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.

What phase is PET Scan with PF-03654746 in?

PET Scan with PF-03654746 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study has been completed.

What clinical trials is PET Scan with PF-03654746 in?

PET Scan with PF-03654746 is associated with one completed Phase 1 clinical trial, NCT00730990, titled "A Phase I, Healthy Volunteer Positron Emission Tomography Study." The trial enrolled 10 healthy male participants in the United States.

Is PET Scan with PF-03654746 FDA approved?

PET Scan with PF-03654746 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial was a controlled study in healthy volunteers.